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186 device results listed.

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MutaPLEX® GBS (Group B Streptococci), PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003064
Basic UDI-DI: B-04050598003064
Reference: KG191032
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:42

Manufacturer products View details

MutaPLEX® GBS (Group B Streptococci), PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002272
Basic UDI-DI: B-04050598002272
Reference: KG191096
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:41

Manufacturer products View details

Toda Strepdiag B 1

Toda Strepdiag B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309513249
Basic UDI-DI: B-03760309513249
Reference: 1010-1
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:59

Manufacturer products View details

Toda Strepdiag B 10

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309513232
Basic UDI-DI: B-03760309513232
Reference: 1010-10
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:59

Manufacturer products View details

Toda Strepdiag A

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309510026
Basic UDI-DI: B-03760309510026
Reference: 1062
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details

STREPTATEST

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532679226605
Basic UDI-DI: B-03532679226605
Reference: 10025
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:48

Manufacturer products View details

STREPTATEST

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678603599
Basic UDI-DI: B-03532678603599
Reference: 10025ND
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:48

Manufacturer products View details

BACTIDROP DESOXYCHOLATE (10%)

BACTIDROP DESOXYCHOLATE

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838023767
Basic UDI-DI: 8488380BDrpDesoxychocZ6
Reference: R21508
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion GBS Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510890
Basic UDI-DI: 54200455DIAGPFGBSS3
Reference: PRD-04484
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX AMPLIFLASH GBS

IVD Class CIVDR 2017/746No longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678599700
Basic UDI-DI: 353267F00157P8N
Reference: 3150072
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

EasyNAT GBS Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240183
Basic UDI-DI: 697349224U2030112C000EU
Reference: U20311
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion GBS Controls Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510906
Basic UDI-DI: 54200455DIAGPFGBSS3
Reference: PRD-04485
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

06955792700901

Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792700901
Basic UDI-DI: 69557927S3056E000001S7
Reference: S3056E-48
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

06955792700895

Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792700895
Basic UDI-DI: 69557927S3056E000001S7
Reference: S3056E-24
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

06950917910555

Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent PCR)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Triplex International Biosciences (China) Co., LTD.
Manufacturer SRN: CN-MF-000001097
UDI-DI: 06950917910555
Basic UDI-DI: B-06950917910555
Reference: C011936
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

Group A Streptococcus Antigen Rapid Test Kit

25 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293581849
Basic UDI-DI: 697518250L118095G
Reference: L11809
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

Group B Streptococcus Antigen Rapid Test Kit

25 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293581832
Basic UDI-DI: 697518250L118104Z
Reference: L11810
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663985307
Basic UDI-DI: B-06939663985307
Reference: ISTA-8112
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Finecare

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289829755
Basic UDI-DI: B-06933289829755
Reference: WW11P0001
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.06.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Strep A

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570091
Basic UDI-DI: B-04719878570091
Reference: PCRAE0107
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.06.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details